FDA approves Teva Pharmaceutical Industries AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination t...
FDA announces two innovation challenges to encourage new approaches for sterilizing medical devices.
Federal Register notice: FDA seeks comments on an information collection extension for its Guidance for Industry on Hypertension Indication: Drug Labe...
Federal Register notice: FDA determines that Novartis Miochol (acetylcholine chloride intraocular solution) was not withdrawn from sale due to safety ...
A new study finds that FDA tends to be more restrictive than its advisory committees when approving new products, new supplemental indications and new...
FDA declines to approve an AstraZeneca supplemental NDA for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycemic control in ...
FDA clears a LivaNova 510(k) for its LifeSPARC system, a new circulatory support pump and controller, intended for use in providing temporary support ...
FDA approves an Abbott PMA for its fourth-generation MitraClip, a heart valve repair device to treat mitral regurgitation.